OPHTEC USA and Advanced Medical Optics Announce U.S. FDA Panel Review Date for the Verisyse -- TM -- Phakic Intraocular Lens.Business Editors/Health/Medical Writers BOCA RATON, Fla. & SANTA ANA, Calif.--(BUSINESS WIRE)--Dec. 22, 2003 OPHTEC USA, Inc., a privately held medical device manufacturer and subsidiary of OPHTEC B.V. (Netherlands), and Advanced Medical Optics Advanced Medical Optics, Inc., (NYSE: EYE) (known as AMO) is a global medical device leader focused on the discovery and delivery of innovative vision technologies that optimize the quality of life for people of all ages. , Inc. (AMO AMO - America's Multimedia Online ) (NYSE NYSE See: New York Stock Exchange :AVO), a global leader in ophthalmic surgical devices and eye care products, announced today that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has confirmed that it will review the Pre-Market Approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) application for the Verisyse(TM) phakic intraocular lens on February 5, 2004. The companies announced on August 22, 2003, that the PMA application had been accepted by the U.S. FDA and been assigned expedited review status. AMO holds global distribution rights to the Verisyse(TM) phakic intraocular lens, which it launched in Europe in 2002, and is the exclusive distributor of the product in North America and Japan. OPHTEC markets the product outside of North America and Japan under the brand name of ARTISAN(R). About the ARTISAN(R) / Verisyse(TM) Phakic Lens The current PMA application is for the correction of near-sightedness, or myopia, in phakic eyes in the range of -5.0D to -20.0D and is the first of several planned product offerings that will include indications for the treatment of farsightedness, astigmatism astigmatism (əstĭg`mətĭz'əm), type of faulty vision caused by a nonuniform curvature in the refractive surfaces—usually the cornea, less frequently the lens—of the eye. , and cataracts -- all of which are currently approved for use in Europe. This unique lens design was conceived by international award-winning ophthalmologist ophthalmologist /oph·thal·mol·o·gist/ (of?thal-mol´ah-jist) a physician who specializes in ophthalmology. oph·thal·mol·o·gist n. A physician who specializes in ophthalmology. Professor Jan Worst, M.D. of Groningen, the Netherlands, and first introduced in 1978 for the correction of aphakia following cataract surgery. Its design was later modified and has been used in the phakic eye for the last 17 years. Since then, over 500,000 lenses with this design have been implanted worldwide. About Phakic IOLs Phakic IOL IOL Intraocular lens, see there implantation, or the implantation of a lens where the natural, human lens still exists, is viewed by many surgeons as becoming an alternative refractive refractive capacity to refract light. refractive error a difference between the focal length of the cornea and lens, and the length of the eye, resulting in myopia or hyperopia. treatment method for myopia, hyperopia and astigmatism. Originally used for the refractive correction of aphakia following cataract surgery, lens implants in Europe and around the world have experienced a renewed level of interest, particularly for patients with high refractive errors. With its unique iris fixation method, OPHTEC's phakic IOL technology enables the lens to attach to the periphery of the iris in a way that does not inhibit the iris' function. Securely anchored, the lens vaults forward, occupying the space between the crystalline lens and the corneal endothelium and provides for the free flow of aqueous from the posterior to the anterior chamber. This type of anterior placement helps to minimize the risk of endothelial cell loss, as well as cataract formation associated with crystalline lens trauma. About OPHTEC USA OPHTEC USA, Inc. is a privately held, wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of OPHTEC BV, Groningen, the Netherlands. OPHTEC designs, manufactures, markets and distributes ophthalmic medical devices used in anterior segment surgery. Primary product lines include ARTISAN(R) Myopia Lenses, ARTISAN(R) Hyperopia Lenses, ARTISAN(R) Toric tor·ic adj. Of, relating to, or shaped like a torus or part of a torus. Lenses, ARTISAN(R) Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. Lenses, ARTIFLEX(TM) Foldable Phakic Lenses, OPHTEC Capsular cap·su·lar adj. Of, relating to, or resembling a capsule. Adj. 1. capsular - resembling a capsule; "the capsular ligament is a sac surrounding the articular cavity of a freely movable joint and attached to the bones" Tension Rings, Custom Artificial Iris Implants and the IPS(TM) Iris Prosthetic System. Worldwide marketing and distribution of products is achieved through direct sales or through exclusive distributorship arrangements. For more information about the company and products contact Rick McCarley, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. at ophtecusa@aol.com, 561-989-8767 or visit the parent company's web site site at www.ophtec.com. About Advanced Medical Optics Advanced Medical Optics, Inc. (AMO) is a global leader in the development, manufacturing and marketing of ophthalmic surgical and contact lens care products. The Company focuses on developing a broad suite of innovative technologies and devices to address a wide range of eye disorders. Products in the ophthalmic surgical line include foldable intraocular lenses, phacoemulsification phacoemulsification /phaco·emul·si·fi·ca·tion/ (-e-mul?si-fi-ka´shun) a method of cataract extraction in which the lens is fragmented by ultrasonic vibrations and simultaneously irrigated and aspirated. systems, viscoelastics and related products used in cataract surgery, and microkeratomes used in LASIK LASIK laser-assisted in-situ keratomileusis. LA·SIK n. Eye surgery in which the surface of the cornea is reshaped using a laser, performed to correct certain refractive disorders such as myopia. procedures for refractive error correction. AMO owns or has the rights to such well-known ophthalmic surgical product brands as Phacoflex(R), Clariflex(R), Array(R) and Sensar(R) foldable intraocular lenses, the Sovereign(R) and Sovereign(R) Compact phacoemulsification systems with WhiteStar(TM) technology and the Amadeus(TM) microkeratome. Products in the contact lens care line include disinfecting solutions, daily cleaners, enzymatic cleaners and lens rewetting drops. Among the well-known contact lens care product brands the Company possesses are COMPLETE(R) Moisture PLUS(TM), COMPLETE(R) Blink-N-Clean(R), Consept(R)F, Consept(R) 1 Step, Oxysept(R) 1 Step, UltraCare(R), Ultrazyme(R), Total Care(R) and blink(TM) branded products. Amadeus is a licensed product of, and a trademark of, SIS, Ltd. Advanced Medical Optics, Inc. is based in Santa Ana, California Santa Ana is the most populous city in Orange County, California and is the county seat. It lies approximately 10 miles inland from the Pacific Ocean, on the largely seasonal Santa Ana River. , and employs approximately 2,000 worldwide. The Company has operations in about 20 countries and markets products in approximately 60 countries. For more information, visit the Company's web site at www.amo-inc.com. Forward-Looking Statements This press release contains forward-looking statements about AMO, OPHTEC, and their businesses such as statements about the FDA approval, product benefits, launch of this product and future product offerings. Any statements in this press release that refer to AMO's anticipated distribution of this and future products, and AMO's estimated or anticipated future results are forward-looking statements. All forward-looking statements in this press release reflect AMO's current analysis of existing trends and information and represent AMO's judgment only as of the date of this press release. Actual results may differ from current expectations based on a number of factors affecting AMO's or OPHTEC's businesses, including but not limited to competitive, regulatory and market conditions; the performance and acceptance of new products and the continuing acceptance of current products; OPHTEC's ability to supply products in sufficient quantity; the execution of strategic initiatives; and the uncertainties associated with intellectual property protection for these products. In addition, matters generally affecting the domestic and global economy can affect AMO's results. Therefore, the reader is cautioned not to rely on these forward-looking statements. AMO disclaims any intent or obligation to update these forward-looking statements. Additional information concerning these and other risk factors may be found in previous financial press releases issued by AMO. AMO's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Certain Factors and Trends Affecting AMO and its Businesses" in AMO's 2002 Form 10-K and in AMO's Form 10-Q for the quarter ended September 26, 2003, also include information concerning these and other risk factors. Copies of press releases and additional information about AMO are available on the World Wide Web at www.amo-inc.com, or you can contact the AMO Investor Relations Department by calling 714-247-8348. |
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